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Data / Medical devices / Probe, Trabeculotomy

Probe, Trabeculotomy (HNK): 29 FDA-registered makers in 11 countries

29 establishments in 11 countries are registered with the FDA to make Probe, Trabeculotomy (product code HNK, Class 1, 21 CFR 886.4350). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HNK
Device class
1
Regulation
886.4350
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States9
India6
Germany5
Pakistan2
Slovakia1
China1
Japan1
Australia1
United Arab Emirates1
Latvia1
Hong Kong1

Makers of Probe, Trabeculotomy

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Akriti Ophthalmic Private LimitedHyderabad Telangana, IndiaManufacturer0000api.fda.gov
Appasamy Associates Private Limited ( Thruvandar Koil)Mannadipet Commune Puducherry, IndiaManufacturer0000api.fda.gov
Appasamy Associates Private Limited (MN Kuppam)Villupuram District Tamil Nadu, IndiaManufacturer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bis MastermedKosice Kosicky, SlovakiaManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Belle Healthcare Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Epsilon Eye Care Pvt., Ltd.MUMBAI Maharashtra, IndiaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Holger Bumueller LLCRutherfordton, NC, United StatesContract manufacturer0000api.fda.gov
Iantrek Inc.Providence, RI, United StatesManufacturer0000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesSpecification developer0000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Paul Instruments (india)CALCUTTA West Bengal, IndiaManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Perfect Ophthalmic Instruments FZEDubai Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
RUMEX Baltics SIARiga, LatviaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Suqian Zhengtong Medical Instruments Co. LtdChina, Hong KongContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.